Clinical trial of an intranasal influenza vaccine
- Registration Number
- CTRI/2019/04/018487
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
1.Normal healthy subjects of >= 2 years at the time of screening.
2.Parent of subject (2-17 years) willing to give written informed consent and willing to comply with study protocol
3.The subject (>=18 year) is willing to give informed consent and willing to comply with study protocol.
4.The subject (07-17 year) is willing to give informed assent and willing to comply with study protocol.
5.Free of obvious health problems as established by medical history, and physical examination.
6.The subject should be the resident of study area.
7.Female subject of child bearing potential must agree not to become pregnant and the male subject must agree not to conceive a child from the time of study enrolment until at least three months after the receiving the study vaccine
1.Acute febrile illness
2.Acute infectious disease or had acute respiratory illness needing antibiotics or antivirals in the previous 7 days (temporary exclusion criteria)
3.Active allergic rhinitis (temporary exclusion criteria)
4.Active wheezing (temporary exclusion criteria)
5.Children or adolescents (2-17 years of age) receiving aspirin therapy or aspirin-containing therapy in the previous 7 days (temporary exclusion criteria)
6.History of influenza infection within one year prior to day of vaccination
7.History of vaccination against influenza within one year prior to day of vaccination
8.Have a known allergy to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein).
9.Women with positive urine pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding or are unwilling to undergo pregnancy testing.
10. Participating in other clinical trial or planned participation in another clinical trial during their entire trial period.
11. Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of study vaccine.
12. History of severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
13. History of Guillain-Barré Syndrome.
14. Major congenital defects or serious chronic illness
15. Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational study agent within previous 30 days or planned during their participation in the study
16. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination, which in the opinion of the investigator might interfere with the study objectives
17. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the subject could complete the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method